Phase I Clinical Research Center
Qingdao, Shandong, 266003, China
NCT Number: NCT05297968
an open label,balanced,randomized,two-treatment,two-period,two-sequence,single dose,crossover,oral bioequivalence Study of oseltamivir phosphate for oral suspension in healthy ,adult,human subjects under fasted/fed conditions.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Qingdao, Shandong, 266003, China
72 healthy adult subjects will be enrolled and randomized in the study.In each period,total 21 venous blood samples (3ml each)will be collected at 0h,10min,20min,30min,45min,1h,1.25h,1.5h,1.75h,2h,2.25h,2.5h,3h,3.5h,4h,4.5h,5h,6h,8h,12h,24h,36h.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
the subjects randomly received single oral administration of Oseltamivir Phosphate For Oral Suspension/Tamiflu 75mg (6mg/ml,12.5ml)
Other names: tamiflu
the subjects randomly received single oral administration of Oseltamivir Phosphate For Oral Suspension 75mg (6mg/ml,12.5ml)
Time frame: up to 1 year
Evaluation of Peak Plasma Concentration (Cmax)
Time frame: up to 1 year
Evaluation of Area under the plasma concentration versus time curve (AUC0-t)
Time frame: up to 1 year
Evaluation of Area under the plasma concentration versus time curve (AUC0-∞)
Time frame: up to 1 year
Analysis of variance (ANOVA) was performed after logarithmic conversion of main pharmacokinetic parameters (Cmax, AUC) to calculate 90% confidence interval of geometric mean ratio of main pharmacokinetic parameters of the two preparations, and equivalence comparison was conducted. The equivalent interval was set to 80.00%~125.00%
Time frame: up to 1 year
Collection of adverse events
The Affiliated Hospital of Qingdao University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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